Occupational Cancer Screening in Firefighters: A Pilot Study Within the Inova Health System
1 other identifier
interventional
800
1 country
1
Brief Summary
The purpose of this study is to further understand the clinical impact and follow-up steps that may be required based on using whole-body Magnetic Resonance Imaging (MRI) or whole-body ultrasound and blood tests to detect multiple cancers in firefighters. This study involves an investigational test (cancer blood test) that has not been approved by the U.S. Food and Drug Administration (FDA). Whole-body MRI and whole-body ultrasound are approved by the U.S. Food and Drug Administration (FDA) to be used in the diagnosis of some cancers and is approved for adults and children who present other signs of potential disease. In this study, however, the whole-body MRI and the whole-body ultrasound are considered investigational devices because they are not yet approved for use in healthy adults with no other cancer indications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Feb 2025
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2025
CompletedFirst Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
April 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
February 27, 2026
April 1, 2025
3.6 years
March 28, 2025
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of confirmed pre-malignancies detected with each investigational screening tool
The number of confirmed pre-malignancies detected using whole-body Magnetic Resonance Imaging (MRI), whole-body ultrasound, or the Multi Cancer Detection (MCD) test
up to 1 year (± 2 months)
Number of confirmed malignancies detected with each investigational screening tool
The number of confirmed malignancies detected using whole-body Magnetic Resonance Imaging (MRI), whole-body ultrasound, or the Multi Cancer Detection (MCD) test
up to 1 year (± 2 months)
Other Outcomes (3)
Sensitivity of each investigational screening tool
up to 1 year (± 2 months)
Specificity of each investigational screening tool
up to 1 year (± 2 months)
Negative predictive value (NPV) of each investigational screening tool
up to 1 year (± 2 months)
Study Arms (2)
Whole Body MRI
ACTIVE COMPARATORPrenuvo whole body magnetic resonance imaging
Whole Body Ultrasound
ACTIVE COMPARATORHigh frequency sound waves
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 35 years old
- at least 10 cumulative years working as a firefighter
- Actively serving as a firefighter (active or volunteer) with completion of NFPA physical examination within the past 6 months
- Ability to understand and willing to sign informed consent
- Ability to understand and willing to sign the Health Insurance Portability and Accountability Act (HIPAA) Authorization
- Additional eligibility criteria in protocol
You may not qualify if:
- No prior history of any invasive cancer within the previous 5 years (non-melanoma skin cancer and in situ carcinoma would still be eligible) and no current diagnostic workup for suspicion of cancer
- Received a whole-body MRI, whole-body ultrasound, or been tested with a MCD within the past 1-year
- For women of childbearing potential, pregnancy and no plans for pregnancy for the duration of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Department of Healthcollaborator
- Inova Health Care Serviceslead
Study Sites (1)
Inova Schar Cancer - Saville Cancer Screening and Prevention Center
Fairfax, Virginia, 22031, United States
Related Publications (18)
LeMasters GK, Genaidy AM, Succop P, Deddens J, Sobeih T, Barriera-Viruet H, Dunning K, Lockey J. Cancer risk among firefighters: a review and meta-analysis of 32 studies. J Occup Environ Med. 2006 Nov;48(11):1189-202. doi: 10.1097/01.jom.0000246229.68697.90.
PMID: 17099456BACKGROUNDJalilian H, Ziaei M, Weiderpass E, Rueegg CS, Khosravi Y, Kjaerheim K. Cancer incidence and mortality among firefighters. Int J Cancer. 2019 Nov 15;145(10):2639-2646. doi: 10.1002/ijc.32199. Epub 2019 Mar 1.
PMID: 30737784BACKGROUNDDemers PA, DeMarini DM, Fent KW, Glass DC, Hansen J, Adetona O, Andersen MH, Freeman LEB, Caban-Martinez AJ, Daniels RD, Driscoll TR, Goodrich JM, Graber JM, Kirkham TL, Kjaerheim K, Kriebel D, Long AS, Main LC, Oliveira M, Peters S, Teras LR, Watkins ER, Burgess JL, Stec AA, White PA, DeBono NL, Benbrahim-Tallaa L, de Conti A, El Ghissassi F, Grosse Y, Stayner LT, Suonio E, Viegas S, Wedekind R, Boucheron P, Hosseini B, Kim J, Zahed H, Mattock H, Madia F, Schubauer-Berigan MK. Carcinogenicity of occupational exposure as a firefighter. Lancet Oncol. 2022 Aug;23(8):985-986. doi: 10.1016/S1470-2045(22)00390-4. Epub 2022 Jul 1. No abstract available.
PMID: 35780778BACKGROUNDPinkerton L, Bertke SJ, Yiin J, Dahm M, Kubale T, Hales T, Purdue M, Beaumont JJ, Daniels R. Mortality in a cohort of US firefighters from San Francisco, Chicago and Philadelphia: an update. Occup Environ Med. 2020 Feb;77(2):84-93. doi: 10.1136/oemed-2019-105962. Epub 2020 Jan 2.
PMID: 31896615BACKGROUNDDaniels RD, Bertke S, Dahm MM, Yiin JH, Kubale TL, Hales TR, Baris D, Zahm SH, Beaumont JJ, Waters KM, Pinkerton LE. Exposure-response relationships for select cancer and non-cancer health outcomes in a cohort of U.S. firefighters from San Francisco, Chicago and Philadelphia (1950-2009). Occup Environ Med. 2015 Oct;72(10):699-706. doi: 10.1136/oemed-2014-102671. Epub 2015 Feb 11.
PMID: 25673342BACKGROUNDDeBono NL, Daniels RD, Beane Freeman LE, Graber JM, Hansen J, Teras LR, Driscoll T, Kjaerheim K, Demers PA, Glass DC, Kriebel D, Kirkham TL, Wedekind R, Filho AM, Stayner L, Schubauer-Berigan MK. Firefighting and Cancer: A Meta-analysis of Cohort Studies in the Context of Cancer Hazard Identification. Saf Health Work. 2023 Jun;14(2):141-152. doi: 10.1016/j.shaw.2023.02.003. Epub 2023 Mar 7.
PMID: 37389311BACKGROUNDKwee RM, Kwee TC. Whole-body MRI for preventive health screening: A systematic review of the literature. J Magn Reson Imaging. 2019 Nov;50(5):1489-1503. doi: 10.1002/jmri.26736. Epub 2019 Apr 1.
PMID: 30932247BACKGROUNDKim A, Chung KC, Keir C, Patrick DL. Patient-reported outcomes associated with cancer screening: a systematic review. BMC Cancer. 2022 Mar 1;22(1):223. doi: 10.1186/s12885-022-09261-5.
PMID: 35232405BACKGROUNDSummers P, Saia G, Colombo A, Pricolo P, Zugni F, Alessi S, Marvaso G, Jereczek-Fossa BA, Bellomi M, Petralia G. Whole-body magnetic resonance imaging: technique, guidelines and key applications. Ecancermedicalscience. 2021 Jan 7;15:1164. doi: 10.3332/ecancer.2021.1164. eCollection 2021.
PMID: 33680078BACKGROUNDZugni F, Padhani AR, Koh DM, Summers PE, Bellomi M, Petralia G. Whole-body magnetic resonance imaging (WB-MRI) for cancer screening in asymptomatic subjects of the general population: review and recommendations. Cancer Imaging. 2020 May 11;20(1):34. doi: 10.1186/s40644-020-00315-0.
PMID: 32393345BACKGROUNDLee SY, Park HJ, Kim MS, Rho MH, Han CH. An initial experience with the use of whole body MRI for cancer screening and regular health checks. PLoS One. 2018 Nov 21;13(11):e0206681. doi: 10.1371/journal.pone.0206681. eCollection 2018.
PMID: 30462666BACKGROUNDConsul N, Amini B, Ibarra-Rovira JJ, Blair KJ, Moseley TW, Taher A, Shah KB, Elsayes KM. Li-Fraumeni Syndrome and Whole-Body MRI Screening: Screening Guidelines, Imaging Features, and Impact on Patient Management. AJR Am J Roentgenol. 2021 Jan;216(1):252-263. doi: 10.2214/AJR.20.23008. Epub 2020 Nov 5.
PMID: 33151095BACKGROUNDHu YS, Wu CA, Lin DC, Lin PW, Lee HJ, Lin LY, Lin CJ. Applying ONCO-RADS to whole-body MRI cancer screening in a retrospective cohort of asymptomatic individuals. Cancer Imaging. 2024 Feb 7;24(1):22. doi: 10.1186/s40644-024-00665-z.
PMID: 38326850BACKGROUNDGeiger KW, Wright TJ, Deters L. Renal Cell Carcinoma as an Incidental Finding in Firefighters: A Case Series. Cureus. 2020 Jul 18;12(7):e9259. doi: 10.7759/cureus.9259.
PMID: 32821605BACKGROUNDPrintz C. New research finds lung cancer screening guidelines are insufficient for firefighters. Cancer. 2020 Feb 15;126(4):692-693. doi: 10.1002/cncr.32721. No abstract available.
PMID: 31995245BACKGROUNDRubinstein WS, Patriotis C, Dickherber A, Han PKJ, Katki HA, LeeVan E, Pinsky PF, Prorok PC, Skarlupka AL, Temkin SM, Castle PE, Minasian LM. Cancer screening with multicancer detection tests: A translational science review. CA Cancer J Clin. 2024 Jul-Aug;74(4):368-382. doi: 10.3322/caac.21833. Epub 2024 Mar 22.
PMID: 38517462BACKGROUNDBrito-Rocha T, Constancio V, Henrique R, Jeronimo C. Shifting the Cancer Screening Paradigm: The Rising Potential of Blood-Based Multi-Cancer Early Detection Tests. Cells. 2023 Mar 18;12(6):935. doi: 10.3390/cells12060935.
PMID: 36980276BACKGROUNDPetralia G, Koh DM, Attariwala R, Busch JJ, Eeles R, Karow D, Lo GG, Messiou C, Sala E, Vargas HA, Zugni F, Padhani AR. Oncologically Relevant Findings Reporting and Data System (ONCO-RADS): Guidelines for the Acquisition, Interpretation, and Reporting of Whole-Body MRI for Cancer Screening. Radiology. 2021 Jun;299(3):494-507. doi: 10.1148/radiol.2021201740. Epub 2021 Apr 27.
PMID: 33904776BACKGROUND
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Stephanie Van Bebber
Inova Health System - Inova Schar Cancer
- PRINCIPAL INVESTIGATOR
Rebecca Kaltman, MD
Inova Health System - Saville Cancer Screening and Prevention Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 17, 2025
Study Start
February 11, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
February 27, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
All data and records generated during this study will be kept confidential in accordance with Inova Health System institutional policies and HIPAA on participant privacy. The Investigator and other site personnel will not use such data and records for any purpose other than conducting the study. No identifiable data will be shared with anyone outside of the authorized Investigators and clinical research staff involved in the study. It is possible that aggregate data results from the project may be shared with other researchers in the future to facilitate pooled analyses or meta-analyses. Individual patient-level data will not be shared.